Table 5.
Table 5.
Table 5. Symbols on packaging (continued) Description Symbol Uncoated device RF Telemetry CHARACTERISTICS AS SHIPPED Refer to the table for pulse generator settings at shipment (Table 6 on page 38). Table 6.
Table 6. Characteristics as shipped (continued) Parameter Setting Pace/Sense Configuration LV: BI/BI (VALITUDE X4 Models) Magnet Rate 100 ppm The pulse generator is shipped in a power-saving Storage mode to extend its shelf life.
• The number, 012, for VALITUDE pulse generators. This identifies the Model 2869 PRM software application needed to communicate with the pulse generator. The number, 011, for INTUA and INVIVE pulse generators. This identifies the Model 2869 PRM software application needed to communicate with the pulse generator. • The x-ray identifier is embedded in the header of the device.
FEDERAL COMMUNICATIONS COMMISSION (FCC) This device complies with Title 47, Part 15 of the FCC rules. Operation is subject to the following two conditions: • This device may not cause harmful interference, and • This device must accept any interference received, including interference that may cause undesired operation.
PULSE GENERATOR LONGEVITY Based on simulated studies, it is anticipated that these pulse generators have average longevity to explant as shown below. The longevity expectations, which account for the energy used during manufacture and storage, apply at the conditions shown in the table along with the following: • Assumes 70 ppm LRL, DDDR mode; 100% biventricular pacing; 15% atrium pacing and 0.4 ms pacing Pulse Width (RA, RV, LV); RA Impedance 500 Ω; sensors On.
Longevities at an LRL of 70 ppm, 500 Ω, 0.5 ms, 100% paced, sensors On, and pacing mode most comprehensive are: All models at 2.5 V = 8.9 years, at 5.0 V = 3.5 years. NOTE: The energy consumption in the longevity table is based upon theoretical electrical principles and verified via bench testing only.
• An additional 6 months in Storage mode prior to implant will reduce longevity by 60 days. Assumes implanted settings of 70 ppm LRL; DDDR mode; 15% atrium pacing; 100% biventricular pacing; 0.4 ms pacing Pulse Width; 500 Ω pacing Impedance; 2.5 V pacing pulse Amplitude (RA, RV); 3.5 V pacing pulse Amplitude (LV).
Table 8. Pulse generator life expectancy estimation (implant to explant) (continued) All Modelsa b Pacing Amplitude a. b. Longevity (years) at 500 Ω and 700 Ω Pacing Impedance (RV and LV) RA/RV LV 500 Ω 700 Ω 3.5 V 3.5 V 6.9 7.8 3.5 V 5.0 V 5.6 6.5 Assumes ZIP wandless telemetry use for 3 hours at implant time and for 20 minutes during each quarterly follow-up.
• • • • • When the Respiratory Sensor is programmed Off for the life of the device, longevity is increased by approximately 4 months. When Patient Triggered Monitor is programmed to On for 60 days, longevity is reduced by approximately 5 days. One hour of additional ZIP wandless telemetry reduces longevity by approximately 9 days. Five patient-initiated LATITUDE Communicator interrogations per week for a year reduces longevity by approximately 14 days.
• • • • Premature battery depletion Sensing or pacing issues Error codes Loss of telemetry Refer to Boston Scientific’s CRM Product Performance Report on www.bostonscientific.com for more information about device performance, including the types and rates of malfunctions that these devices have experienced historically. While historical data may not be predictive of future device performance, such data can provide important context for understanding the overall reliability of these types of products.
• Activity restrictions (if applicable) • Minimum heart rate (lower rate limit of the pulse generator) • Frequency of follow up • Travel or relocation—Follow-up arrangements should be made in advance if the patient is leaving the country of implant • Patient ID card—the patient should be advised to carry their patient ID card at all times (a temporary patient ID card is provided with the device, and a permanent ID card will be sent to the patient 4 to 6 weeks after the implant form is received by B
The following lead connections apply to VALITUDE devices. IS–1 UNI/BI RA IS–1 RV IS–1 LV UNI/BI UNI/BI [1] RA: White [2] RV: White [3] LV: Green [4] RA [5] RV [6] LV [7] Suture Hole Figure 2.
IS–1 UNI/BI RA IS–1 UNI/BI RV IS4–LLLL LV [1] RA: White [2] RV: White [3] LV: Green [4] RA [5] RV [6] LV [7] Suture Hole Figure 3. Lead connections and setscrew locations, RA: IS-1, RV: IS-1, LV: IS4-LLLL The following lead connections apply to INTUA and INVIVE devices.
IS-1 LV IS-1 RA IS-1 RV UNI/BI UNI/BI UNI/BI [1] LV [2] RA [3] RV [4] Suture Hole Figure 4. LV-1 LV IS-1 RA IS-1 RV UNI/BI UNI/BI UNI/BI Lead connections and setscrew locations, RA: IS-1, RV: IS-1, LV: IS-1 [1] LV [2] RA [3] RV [4] Suture Hole Figure 5. Lead connections and setscrew locations, RA: IS-1, RV: IS-1, LV: LV-1 NOTE: The pulse generator case is used as a pace electrode when the pulse generator has been programmed to a unipolar lead setting.
IMPLANTING THE PULSE GENERATOR Implant the pulse generator by performing the following steps in the sequence provided. Some patients may require pacing therapies immediately upon connecting the leads to the pulse generator. If modifications to the nominal settings are needed, consider programming the pulse generator before or in parallel with implanting the lead system and forming the implantation pocket.
To begin a ZIP telemetry session for VALITUDE devices, verify that the ZOOM Wireless Transmitter is connected to the PRM via the USB cable and that the green light on top of the transmitter is illuminated. To initiate communication with all devices, position the wand over the PG and use the PRM to Interrogate the pulse generator.
NOTE: If a coronary venous lead cannot be used and the physician’s medical judgment indicates that a limited left thoracotomy is justified to place an epicardial lead, the use of either a sutureable, steroid-eluting pace/sense epicardial lead or sutureless epicardial pace/sense lead is recommended. CAUTION: The absence of a lead or plug in a lead port may affect device performance. If a lead is not used, be sure to properly insert a plug in the unused port, and then tighten the setscrew onto the plug.
WARNING: For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. This could damage the lead terminal, possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as a short within the header.
Table 9. Lead measurements (continued) Pace/ sense lead (acute) Pace/ sense lead (chronic) Lead impedance (at 5.0 V and 0.5 ms atrium and right ventricle) > programmed Low Impedance Limit (200–500 Ω) < 2000 Ω (or the programmed High Impedance Limit (2000–3000 Ω)) > programmed Low Impedance Limit (200–500 Ω) < 2000 Ω (or the programmed High Impedance Limit (2000–3000 Ω)) Lead impedance (at 5.0 V and 0.
Step E: Form the Implantation Pocket Using standard operating procedures to prepare an implantation pocket, choose the position of the pocket based on the implanted lead configuration and the patient’s body habitus. Giving consideration to patient anatomy and pulse generator size and motion, gently coil any excess lead and place adjacent to the pulse generator. It is important to place the lead into the pocket in a manner that minimizes lead tension, twisting, sharp angles, and/or pressure.
If the leads are not connected to a pulse generator at the time of lead implantation, they must be capped before closing the incision. Step F: Connect the Leads to the Pulse Generator To connect leads to the pulse generator, use only the tools provided in the pulse generator sterile tray or accessory kit. Failure to use the supplied torque wrench may result in damage to the setscrews, seal plugs, or connector threads. Do not implant the pulse generator if the seal plugs appear to be damaged.
Leads should be connected to the pulse generator in the following sequence (for pulse generator header and setscrew location illustrations, refer to "Lead Connections" on page 48): a. Right ventricle. Connect the RV lead first because it is required to establish RV-based timing cycles that yield appropriate sensing and pacing in all chambers, regardless of the programmed configuration.
c. Gently insert the torque wrench blade into the setscrew by passing it through the preslit, center depression of the seal plug at a 90° angle (Figure 6 on page 60). This will open up the seal plug, relieving any potential pressure build-up from the lead port by providing a pathway to release trapped fluid or air. NOTE: Failure to properly insert the torque wrench in the preslit depression of the seal plug may result in damage to the plug and its sealing properties.
d. With the torque wrench in place, fully insert the lead terminal into the lead port. The lead terminal pin should be clearly visible beyond the connector block when viewed through the side of the EasyView pulse generator header. Place pressure on the lead to maintain its position and ensure that it remains fully inserted in the lead port. CAUTION: Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface.
Step G: Evaluate Lead Signals 1. Insert the pulse generator into the implantation pocket. 2. Evaluate the pace/sense lead signals by viewing the real-time EGMs and markers. Lead measurements should reflect those above (Table 9 on page 55). Depending on the patient’s intrinsic rhythm, it may be necessary to temporarily adjust pacing parameters to allow assessment of pacing and sensing.
Consider the following factors when choosing a value for the impedance limits: • For chronic leads, historical impedance measurements for the lead, as well as other electrical performance indicators such as stability over time • For newly implanted leads, the starting measured impedance value NOTE: Depending on lead maturation effects, during follow-up testing the physician may choose to reprogram the impedance limits.
• When programming MSR, consider the patient’s condition, age, general health and that adaptive-rate pacing at higher rates may be inappropriate for patients who experience angina or other symptoms of myocardial ischemia at these higher rates. An appropriate MSR should be selected based on an assessment of the highest pacing rate that the patient can tolerate well.
Connections" on page 48). Gently coil excess lead and place adjacent to the pulse generator. Flush the pocket with saline solution, if necessary, to avoid a dry pocket. WARNING: Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. 3. Close the implantation pocket. Consideration should be given to place the leads in a manner to prevent contact with suture materials.
BIDIRECTIONAL TORQUE WRENCH A torque wrench (model 6628) is included in the sterile tray with the pulse generator, and is designed for tightening and loosening #2-56 setscrews, captured setscrews, and setscrews on this and other Boston Scientific pulse generators and lead accessories that have setscrews that spin freely when fully retracted (these setscrews typically have white seal plugs).
4. Once the setscrew has been freed, it may be extended or retracted as appropriate. 5. Discard the torque wrench upon completion of this procedure. 20°–30° [1] Clockwise rotation to free setscrews stuck in the retracted position [2] Counterclockwise rotation to free setscrews stuck in the extended position Figure 7.
FOLLOW UP TESTING It is recommended that device functions be evaluated with periodic follow-up testing by trained personnel. Follow up guidance below will enable thorough review of device performance and associated patient health status throughout the life of the device. Predischarge Follow Up The following procedures are typically performed during the predischarge follow up test using PRM telemetry: 1. Interrogate the pulse generator and review the Summary screen. 2.
NOTE: Because the duration of the device replacement timer is three months (starting when Explant status is reached), three month follow up frequency is particularly important after the One Year Remaining status is reached. Consider performing the following procedures during a routine follow-up test: 1. Interrogate the pulse generator and review the Summary screen. 2. Verify pacing thresholds, lead impedance, and amplitude of intrinsic signals. 3.
WARNING: Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
• Deactivate the pulse generator before explantation. • Disconnect the leads from the pulse generator. • If leads are explanted, attempt to remove them intact, and return them regardless of condition. Do not remove leads with hemostats or any other clamping tool that may damage the leads. Resort to tools only if manual manipulation cannot free the lead. • Wash, but do not submerge, the pulse generator and leads to remove body fluids and debris using a disinfectant solution.
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For additional reference information, go to www.bostonscientific.com/ifu. Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112–5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2014 Boston Scientific Corporation or its affiliates. All rights reserved.
